Improving the Efficacy of Anti-Nicotine Immunotherapy (PETNic002)

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Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

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Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

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Reporting Groups

Description

NIC002 Vaccine in Aluminum Hydroxide

4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.

Placebo Vaccine - Aluminum Hydroxide

4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

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Reporting Groups

Description

NIC002 Vaccine in Aluminum Hydroxide

4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.

Placebo Vaccine - Aluminum Hydroxide

4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.

Total

Total of all reporting groups

Baseline Measures

NIC002 Vaccine in Aluminum Hydroxide

Placebo Vaccine - Aluminum Hydroxide

Total

Overall Participants Analyzed [Units: Participants]

45

7

52

Age, Customized [1] [Units: Years]Mean (Full Range)

43
(23 to 56)

44
(35 to 55)

43
(23 to 56)

[1]

One participant reported that she was 54 at the screening, but after she was consented, it was discovered that she was actually 56. However, the subject was discontinued after the first study visit because she could not use the smoking delivery device; therefore, she received no vaccinations. Safety Event #14 was submitted to Duke IRB to account for this Protocol Deviation in which the subject was out of the age range.

Gender [Units: Participants]

Female

22

4

26

Male

23

3

26

Region of Enrollment [Units: Participants]

United States

45

7

52

Cigarettes Per Day [1] [Units: Cigarettes per day]Mean (Full Range)

19
(10 to 30)

21
(16 to 30)

19
(10 to 30)

[1]

average number of cigarettes participant smokes each day

Pack-Years [1] [Units: Pack-years]Mean (Full Range)

22
(4 to 45)

25
(18 to 32)

22
(4 to 45)

[1]

pack-years that each participant has smoked, calculated by multiplying the number of packs of cigarettes participant smokes each day by number of years participant has smoked